MAUDE Adverse Event Report: CAREFUSION, INC CHLORAPREP ONE STEP; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL

Catalog Number 270400

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

It was reported that the chloraprep applicator did not have any solution after breaking the ampoule and applying to patient's skin.

Event Description

It was reported that the chloraprep applicator did not have any solution after breaking the ampoule and applying to patient's skin.

Manufacturer Narrative

A photo has been provided for evaluation.This photo unfortunately does not provided any evidence to perform an investigation as it only shows the outer carton packaging and not the product affected.As a result, this failure mode could not be verified and a root cause could not be defined at this time.Production record review could not be completed as no lot information were provided.No previous complaint from the same product code and lot (unk) related to complaint code ¿solution dried / missing / not enough¿ have been received from august 2018 to august 2020.No adverse trend observed, defect is within control limits.No further actions required at this time.This failure mode will continue to be tracked and trended h3 other text : see narrative below.

• Brand Name: CHLORAPREP ONE STEP
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 10469898
• MDR Text Key: 204957845
• Report Number: 3004932373-2020-00022
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 270400
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 08/04/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other